Clemastine Fumarate

Product NDC: 54838-514
11-digit product format: 548380514
Labeler code: 54838
Product ID: 54838-514_00a84afa-9348-4cd4-8151-2afab977ea09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clemastine Fumarate
Dosage form: SYRUP
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA074884
Marketing category: ANDA
Marketing start: 1997-12-17
Marketing end: 0000-00-00
Substance: CLEMASTINE FUMARATE
Active strength: 1 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54838-514		D	Discontinued by firm	2026-08-17
excluded package	package	54838-514	54838-514-40	D	Discontinued by firm	2026-08-17
excluded package	package	54838-514	54838-514-80	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54838-514-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54838-514-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54838-514-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54838-514-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54838-514-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54838-514-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54838-514-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54838-514-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54838-514-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54838-514-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54838-514-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54838-514-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54838-514-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54838-514-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54838-514-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54838-514-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54838-514-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54838-514-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54838-514-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54838-514-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54838-514-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54838-514-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54838-514-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54838-514-40	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074884-001	CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA		1997-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074884-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL	AA	1997-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074884-001	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML	SYRUP / ORAL		1997-12-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074884-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074884-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074884-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074884-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074884-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074884-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074884-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074884-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074884-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074884-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074884-001	AA	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074884-001	AA	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-514-40	ML - Milliliter	54838-514	16bada56-5809-4468-be6b-1798356fdfbb	1	2012-07-24
54838-514-80	ML - Milliliter	54838-514	ab2ae5e6-c4b0-40ef-ba1a-1eb3d6f2622f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clemastine Fumarate	ACTIVE INGREDIENT	19259EGQ3D	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
Clemastine	ACTIVE MOIETY	95QN29S1ID	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
alcohol	INACTIVE INGREDIENT	3K9958V90M	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
fumaric acid	INACTIVE INGREDIENT	88XHZ13131	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
saccharin sodium dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
sorbitol	INACTIVE INGREDIENT	506T60A25R	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9
water	INACTIVE INGREDIENT	059QF0KO0R	CLEMASTINE FUMARATE SYRUP [SILARX PHARMACEUTICALS, INC]	9

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	Chartwell RX, LLC	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	2023-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074884 application number: ANDA074884

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19259EGQ3D	CLEMASTINE FUMARATE	14976-57-9	CLEMASTINE FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54838-514-40	54838051440	120 mL in 1 BOTTLE, PLASTIC (54838-514-40)	120 ml	1997-12-17	0000-00-00	No	No	Current
54838-514-80	54838051480	473 mL in 1 BOTTLE, PLASTIC (54838-514-80)	473 ml	1997-12-17	0000-00-00	No	No	Current